Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04050280
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2019-07-16
Brief Title:
CLAG-GO for Patients With Persistent Relapsed or Refractory AML
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase II Study of Cladribine Cytarabine and Granulocyte-Colony Stimulating Factor With Fractionated Gemtuzumab Ozogamicin CLAG-GO for the Treatment of Patients With Persistent Relapsed or Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves evaluating a combination of chemotherapy drugs known as CLAG-GO cladribine cytarabine granulocyte-colony stimulating factor G-CSF and gemtuzumab ozogamicin GO in the treatment of acute myeloid leukemia AML that has not responded well to standard therapy or has returned after an initial remission relapsed The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center UMGCCC Potential participants will go through a screening period to see if they are eligible to join the study If eligible participants will be hospitalized for 4-5 weeks to receive study treatment with CLAG-GO called induction chemotherapy If tests show that the cancer is in remission after induction chemotherapy participants may undergo further chemotherapy known as consolidation or may proceed with bone marrowstem cell transplantation Patients who receive consolidation chemotherapy and remain in remission may have up to 8 cycles of outpatient maintenance therapy A cycle lasts about 28 days All participants will be monitored carefully for both side effects and to see if the study treatment is working Lab tests and exams will be conducted throughout the entire study In addition special studies will be done at various time points to try to understand better how the drugs work and which patients are likely to respond best
Detailed Description:
This is a single-arm two-stage phase II trial of cladribine cytarabine granulocyte colony stimulating factor and gemtuzumab ozogamicin CLAG-GO in adult patients with acute myeloid leukemia AML who are either have persistent disease after initial induction chemotherapy or are in first relapse with early stopping for unacceptable toxicity The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center UMGCCC with a target enrollment of 39 patients if the trial proceeds to the second stage Eligible patients will receive induction chemotherapy with CLAG-GO at the doses detailed below In the first stage of the trial a sequential boundary is used to monitor induction mortality and halt accrual if this mortality is significantly above 10 If more than 6 responses are seen in the initial 19 patients 20 additional patients will be enrolled in the 2nd stage Responders may proceed to allogeneic hematopoietic stem cell transplantation alloHSCT at any time after induction and these patients will be monitored for at least 30 days post-transplantation for veno-occlusive disease Responding patients will also have the option of having a single cycle of consolidation therapy using the same CLAG-GO regimen followed by maintenance with GO monotherapy for up to 8 additional cycles Responses will be categorized according to the European LeukemiaNet ELN response criteria for AML Assessment of measureable residual disease MRD will be conducted with bone marrow aspirate samples and changes in immunophenotype will be evaluated In addition single nucleotide polymorphism SNP analysis and sialylation status of CD33 along with sialidase activity of myeloblasts will be evaluated and correlated with responses and survival times Safety and toxicity will be evaluated continuously and event-free survival and overall survival as well as the proportion of patients proceeding to receive alloHSCT will be estimated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None